Clinical Monitoring

You want fast subject recruitment, compliant site performance and reliable data. You need efficient trial monitoring and well prepared clinical trial sites.

Monitors are the backbone of your clinical trial. Accovion monitors:

  • Protect the rights, safety and well-being of your clinical trial subjects
  • Oversee the progress of your clinical trial
  • Support fast recruitment
  • Ensure protocol compliance
  • Apply SOPs, GCP and applicable regulatory requirements
  • Ensure accurateness and reliability of clinical data
  • Help to increase acceptance of clinical data by the regulatory authorities

Monitoring is a major cost factor in your clinical trial budget. Investing the money in an efficient monitoring service that considers the priority and complexity of your project without compromising quality is crucial for success. Accovion helps you to find the right solutions and offers much more for your clinical trial, including:

  • Feasibility studies and concepts
  • Assessments of sites and investigator qualifications
  • Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling)
  • Ethics committee and regulatory authority submissions
  • Investigator Site File compilation and review
  • Translation of study-specific documents including quality check
  • GCP monitoring
  • Site management, including telephone monitoring and proactive issue handling
  • Study logistics support
  • Support for site audits and inspections
  • Preparation of investigator meetings
  • State-of-the-art study / project management, including risk management
  • Support of Data Monitoring Committees
  • Intensive training sessions during investigator meetings (e.g. GCP, safety reporting, IMP handling)
  • Supporting analysis on data quality and timeliness as well as on individual investigational site performance
  • Detailed working instructions (e.g. via e-mail or EDC system)
  • Newsletters on trial progress or trial-specific topics (e.g. protocol compliance and how to archive it, GCP or most common misunderstandings of the CRF)
Contact us

Daniela Mellwig
Head Clinical Monitoring

+49 6196 7709-224

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